French Observatory of Rare Malignant Tumors of the Ovary | NCT01304043

Studies
French Observatory of Rare Malignant Tumors of the Ovary

NCT01304043

Sponsor

ARCAGY/ GINECO GROUP

Status

Completed

Last Update Posted

Apr 20, 2012Estimated

Enrollment

204Actual

Phase

Not provided

Conditions

Ovarian Tumors

Interventions

chemotherapies protocols

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Not provided

Completion Date

Jun 2011Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Feb 24, 2011

First Posted Date

Feb 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2012

Last Update Posted Date

Apr 20, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To take charge of the treatment in rare adult ovarian tumors with an homogenous manner (germinal and sexual cords tumors), at different stages of the disease.

Detailed Description

to establish prognosis factors for the disease
to proceed in a centralised examination of histologic laminas
to reach in the long-term and homogenous follow-up of the patients
to follow-up the long-term toxicities of the treatments given
to analyse and follow-up the later fertility of the patients
to evaluate the interest of setting a multi-disciplinary discussion forum on the Web

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

204Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
chemotherapies protocols	Drug	Cisplatine 20 mg/m² IV Etoposide 100 mg/m² IV Bléomycine 30 mg IV

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18 years old
germinal or sexual cords ovary tumors histologically proven
first line or relapse treatment
written informed consent

Exclusion Criteria:

mental ineptitude to understand and follow the study

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

female with rare ovarian cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isabelle Ray-Coquard, Physician	GINECO	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame		Paris		75004	France

References Module

Citations

Not provided

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases